APL(PML-RARA) QUANT

Test Code

510840

Alias/See Also

"15;17 Translocation Detection by RT-PCR
APL
"

CPT Codes
81315

Preferred Specimen

"Whole blood or bone marrow
3-5 mL whole blood or 1-2 mL bone marrow
"

Minimum Volume

"3 mL whole blood or 1 mL bone marrow
"

Instructions

"Specimens must arrive in laboratory within 48 hours of collection. Indicate date and time of collection on test request form. Please direct any questions regarding this test to customer service at 800-345-4363.
"

Transport Container

"Lavender-top (EDTA) tube, green-top (sodium heparin) tube, or yellow-top (ACD-A) tube
"

Transport Temperature

room temp

Specimen Stability

"Ship at room temperature. If specimen is to be stored prior to shipment, store at 2°C to 8°C.
"

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Specimen more than 48 hours old; clotted blood

Methodology
"TaqMan® quantitative polymerase chain reaction (Q-PCR) "

Limitations

"Absence of a detectable rearrangement does not exclude the possibility of the presence of low levels of transcript below the level of detection of this assay, or a rearrangement outside the analyzed breakpoint regions. Fluorescence in situ hybridization (FISH) is recommended to detect rare variant breakpoints or other translocations associated with APL.
"

Clinical Significance

"The translocation t(15;17) (q22;q21) is the prototype rearrangement found in the vast majority of acute promyelocytic leukemia (APL), being found in >95% of APL cases. In this chromosomal rearrangement, the retinoic acid receptor (RARA) gene on chromosome 17 is fused with the PML gene on chromosome 15. There are three common breakpoints within the PML gene, bcr1 (intron 6), bcr2 (exon 6), and bcr3 (intron 3). All breakpoints fuse a portion of the PML gene to a consistent breakpoint region within the RARA gene. This assay will detect the PML-RARA transcripts associated with the bcr1, bcr2, and bcr3 breakpoints using real-time RT-PCR in order to assist in the diagnosis of APL. In vitro studies have indicated that this assay has an analytical sensitivity that allows for the detection of 10 or more copies of the PML-RARA fusion transcript.
"

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.